Evaluation of the Scalp Skin Care Effects of Premium Revitalizing Elixir
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Sebum Content
研究概览
简要总结
The study aims to evaluate the efficacy of the Premium Revitalizing Elixir on human scalp skin. A total of 60 healthy adults, aged 18 to 60 with alopecia, baldness, or self-identified with symptoms of hair thinning will be recruited and randomly assigned into five groups receiving different formulations. Participants will use the product once daily for 56 days, and their scalp conditions will be assessed through skin texture tests at multiple time points. Key parameters such as sebum content, overall hair loss, hair density, scalp condition, and hair length will be measured. A self-assessment and assessment by a hair specialist on hair and scalp condition will also be provided at the end of the study (Day 56).
详细描述
This is a prospective, randomized, double-blinded, and placebo-controlled study to investigate the effects of Premium Scalp Revitalizing Essence on changes in the skin texture of human scalp skin.
This study aims to enroll 60 healthy adults aged from 18 to 60 with alopecia, baldness, or self-identified with symptoms of hair thinning.
Inclusion criteria include healthy adults defined as individuals without chronic diseases, significant illnesses (including cancer, post-stroke disorders, paralysis, acute myocardial infarction, coronary artery bypass surgery, end-stage renal disease, and major organ transplant or hematopoietic stem cell transplant), or allergic constitutions, and who are not currently taking any medication or using any scalp care products.
Exclusion criteria include individuals who are pregnant or breastfeeding, as well as males or females with chronic diseases, significant illnesses, or allergic constitutions, currently using scalp care products, students or employees affiliated with the principal investigator, individuals with scalp wounds, those who have participated in cosmetic product testing, and those who have undergone scalp aesthetic treatments within the past three months.
The participants will be randomly assigned into five groups, with 12 individuals in each group. Group 1 uses Placebo (Base formula without caffeine and panthenol); Group 2 uses the Base formula (Control with 0.1% caffeine and panthenol); Group 3 uses Base + IGF-1 & FGF-7; Group 4 uses Base + Centella asiatica extracellular vesicles + Ginger-derived extracellular vesicles; Group 5 uses Base + Centella asiatica extracellular vesicles + Ginger-derived extracellular vesicles + IGF-1 & FGF-7. Before using the test product, all 60 participants undergo the first scalp skin texture test. After 14 days of using the test product, a second scalp skin texture test is conducted; after 28 days of use, a third test is performed; after 42 days of use, a fourth test is conducted; and after 56 days of use, a fifth test is carried out. The scalp skin texture tests include measurements of skin (1) sebum content, (2) overall hair loss, (3) hair density, (4) scalp condition, (5) hair length, and other parameters. The Sebumeter® SM815 probe of the MPA580 device and the ScalpX Intelligent Scalp Diagnostic System will be used to measure the parameters of the study. On Day 56, the participants will be asked to fill out a self-assessment form and a hair specialist will also assess the hair and scalp condition at the end of the study.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Care Provider, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Healthy adults of any gender from the age of 18 to 60 years (inclusive).
- •Having symptoms of alopecia, baldness, or self-identified with hair thinning.
- •Absence of chronic diseases, major illnesses, or allergies.
- •Major illnesses include cancer, post-stroke disorders, paralysis, acute myocardial infarction, coronary artery bypass surgery, end-stage renal disease, and major organ transplant or hematopoietic stem cell transplant
排除标准
- •Currently taking any medication or using any scalp care products
- •Pregnant or breastfeeding
- •Chronic diseases, significant illnesses, or allergic constitutions
- •Currently using scalp care products
- •Students or employees affiliated with the principal investigator,
- •Individuals with scalp wounds
- •Participated in cosmetic product testing
- •Undergone scalp aesthetic treatments within the past three months.
研究组 & 干预措施
Group 4: Base formula plus Centella asiatica and ginger extracellular vesicles
Base formula plus Centella asiatica and ginger (Zingiber officinale) extracellular vesicles
干预措施: Base formula plus Centella asiatica and ginger extracellular vesicles (Other)
Group 5: Base formula plus Centella asiatica and ginger extracellular vesicles, IGF-1 & FGF-7.
Base formula plus Centella asiatica and ginger (Zingiber officinale) extracellular vesicles, insulin growth factor-1 (IGF-1) and fibroblast growth factor-7 (FGF-7).
干预措施: Base formula plus Centella asiatica and ginger extracellular vesicles, IGF-1 & FGF-7 (Other)
Group 1: Placebo control
Base formula without caffeine and panthenol
干预措施: Placebo control (Other)
Group 2: Base formula only
Base formula consisting of active ingredients 0.1% caffeine and panthenol (vitamin B5).
干预措施: Base formula only (Other)
Group 3: Base formula plus IGF-1 & FGF-7.
Base formula plus insulin growth factor 1 (IGF-1) and fibroblast growth factor-7 (FGF-7)
干预措施: Base formula plus IGF-1 and FGF-7 (Other)
结局指标
主要结局
Sebum Content
时间窗: Assessment conducted every 14 days from Day 0 to Day 56 (including Day 0 as baseline)
Assess oil levels on the scalp at standardized scalp sites (left, right, and vertex). Measured with C+K Multi Probe Adaptor MPA580 system using the Sebumeter® SM815 probe based on the grease spot photometry method with the sebum measurement cassette tape.
Hair length
时间窗: Assessment conducted every 14 days from Day 0 to Day 56 (including Day 0 as baseline)
Hair length (cm): Measured manually with ruler at standardized scalp sites (left, right, and vertex).
Hair density
时间窗: Assessment conducted every 14 days from Day 0 to Day 56 (including Day 0 as baseline)
Hair density (number of hairs/cm-square): Assessed with the ScalpX Intelligent Scalp Diagnostic System with digital microscopy at standardized scalp sites (left, right, and vertex).
Hair thickness
时间窗: Assessment conducted every 14 days from Day 0 to Day 56 (including Day 0 as baseline)
Hair thickness (micrometers): Assessed with the ScalpX Intelligent Scalp Diagnostic System with digital microscopy at standardized scalp sites (left, right, and vertex).
Hair loss
时间窗: Assessment conducted every 14 days from Day 0 to Day 56 (including Day 0)
Hair loss: Assessed by the standardized hair combing test by counting the number of hairs shed after the participants' hair was combed over a clean surface for 60 strokes.
次要结局
- Participant self-assessment(Day 56 (End of the study period))
- Hair specialist assessment(Day 56 (End of the study))
研究者
Tsong-Min Chang
Vice President
Hungkuang University